I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started.

I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so.

"They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating."

and i would have been doing just fine, until i asked my question. i was surprised my time to ask a question so quick.

(understand, these are taken from my notes for now. the spelling of names and such could be off.)

[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.

[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]

[host Richard] could you repeat the question?

[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

[not sure whom ask this] what group are you with?

[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.

[not sure who is speaking] could you please disconnect Mr. Singeltary

[TSS] you are not going to answer my question?

[not sure whom speaking] NO

from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;

[unknown woman] what group are you with?

[TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now?

at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference.

IF i were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from;

RBARNS@ORA.FDA.GOV 301-827-6906

he would be glad to give you one ;-)

Rockville Maryland, Richard Barns Host

SNIP...END...TSS

============================================

Freas, William

Monday, January 08,200l 3:03 PM

Consultants Staff January 2001 Meeting (short version)

Last, but not least. The illegal/legal harvesting of body parts and tissues will come back to haunt you. Maybe not morally, but due to NO background checks and human TSEs, again it will continue to spread.

Stupidity, Ignorance and Greed is what fuels this disease. You must stop all of this and ACT AT ONCE...

The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.

TIP740203/l 0424 CONFIDENTIAL

http://www.mad-cow.org/00/may00_news.html

From: Terry S. Singeltary Sr. (216-119-138-152.ipset18.wt.net)Subject: COMMERCIAL IN CONFIDENCE/BSE/SURGICAL IMPLANTS/BLOOD CONTACT DEVICES (1989)Date: August 31, 2000 at 1:46 pm PSTGreetings,thought i would make a comment on some of these old documentsi have been posting, still more to come. But i am trying to showthe pattern of deceipt and lies that surround this pendingenvironmental worldwide human/animal catastrophe. If i have not proven it yet, to EVERYONE, i will, just give me a little more time, my scanner and myself can only go so fast....thanks,Terry S. Singeltary Sr., Bacliff, Texas USA============================================COMMERCIAL IN CONFIDENCEMiss M Duncan From: Dr E HoxeyDate: 29 January 1990cc: Mr R BurtonDr N RichardsonMs K TurnerMs J DhellMr N WeatherheadBOVINE SPONGIFORM ENCEPHALOPATHY1. In your absence on sick leave, I chaired the STD BSE group meetingon 26th January 1990.2. The minutes of the meeting will be circulated shortly but I was askedto bring to your attention the concerns of the group regarding the BMSheart valve.3. This concern arose from a number of points on the agenda:-i) the______________decision to source all raw material for suturesfrom Australasia from January 1990.ii) the major cleandown and decontamination proposed for thefactory and the possibility of press interest that this may generate.iii) the indication in the Tyrell Report on Research that theinfective agent may be induced to cross the species barrier byintracerebral, intraperitoneal or intravenous injection.4. As you are aware, the____________situation has been a model which wehave observed closely.5. Reviewing the BMS situatien, we considered the incidence of BSE inthe herds used for materials, the processing received by the materialand the age of the cattle used. Given the number of uncertainties andlack of definitive information on BSE, the_______________model wasstill considered as a good one. The group were uncomfortable with theposition of BMS as the only company using UK sourced material.6. The group considered that it may be worthwhile arranging a furthermeeting with___________to confidentially make them aware that theywould now be the only company using UK sourced bovine material forproducts of this type.7. Clearly, __________and__________ are now in an exposed position inthis area and all the implications need te be considered. Could we haveyour news on this proposal please?Dr E V HoxeyPD STD PG1A716 RSQExt 335690/01.29/19.1==============B.S.E. GUIDELINES ON BOVINE IMPLANTS & BLOOD CONTACT DEVICES -MEETING WITH MANUFACTURERSDATE: 8 DECEMBER 1989DH REPRESENTATIVES Nigel RichardsonWill BurtonEammon HoxeyJeremy TinklerHelen CampbellCarol BleakleyBill WaineThe main purpose of the meeeting is to discuss the companies currentmanufacturing procedures, future plans and their compliance with theBSE guidelines. Their views were also sought as to the practicalfeasibility of the guidelines with respect to the manufacturingprocess, and any improvements that could be suggested.The meetings were held separately with each company. Neither hadreceived any queries concerning BSE from countries to which theirproducts are exported.CURRENT POSITION1.__________ have brought in a microbiologist as a technical scientificadviser, initially to inform them of the current understanding ofBSE. He is still available to them and keeps them up to date with newdevelopments.2. At present they produce bovine pericardial heart valves, & (a sistercompany) produces heparin coated products (from a porcine source). Inthe future it is possible that they will introduce a bovine patchproduced from bovine pericardium from the same source. They will keepthe Department informed of any progress in this area.SOURCE MATERIAL3. The source material for the manufacture of heart valves is bovinepericardial sacs. The cows used are 18-24 months old when slaughtered,the majority around 18 months. BMS have no knowledge of the actualage.4. The cows are killed using brain penetration. Dr Bleakley made thepoint that as far as she was aware this was the only method used inthis country. Meat inspectors are paid to obtain the bovinepericardium. They are paid a set rate but bonuses are given forincreased yields. Mr Burton expressed concern as to the conflict ofinterests that may arise as a result of this. Dr Bleakley did notbelieve that this was the case because of the relationship BMS haddeveloped with the inspectors.89/12.12/8.1============COMMENTS ON THE GUIDELINES14. Dr. Bleakley believed that the pericardium would not allow thereplication of the causative agent, and does not present a risk.15. She suggested that the guidelines were impossible to implementfrom the point of view of the manufacturing process for the followingreasons:--It is not possible to use closed herds simply because of the numbersof cattle involved. This is up to 800 each week.-Calves under 6 months old cannot be used as the pericardium is toothin to be incorporated into a valve.-For cows this in the age group used brain penetration is the onlymethod of slaughtering used in this country.PROPOSALS PUT FORWARD BY DR BLEAKLEY16. The goverment should fund research in this area. For example,investigating the presence or absence of the infectious agent inother parts of the body, such as the pericardium. Also to look at howthe slaughtering process affects the spread of the disease.17. Ideally the answer would be to take random tissue samples inorder to detect contaminated material. This is not currently feasiblewith the length of time required to conduct titre testing.COMMENTS ON THE REVIEW ON METHODS OF STERILIZATION FOR BSE18. Everything present reflected the published material, but thevalidity of some of this is questionable. It was pointed out that:--it was stated that different strains display different heatsensitivity, but this does not appear to be chemically related-the claim to be "effective' would depend on the type of material thatwas being used and the time involved.CURRENT POSITION19.____________ manufacture porcine valves and bovine pericardialpatches. The possibility of producing porcine conduits is currentlybeing investigated. This has not yet progressed.20. The material is obtained from 2 abattoires in this country:--Dorchester, where veal calves under 18 weeks are slaughtered forsourcing pericardium for ________________. These are used to producesmall patches of less than 90mm diameter, this may be divided into 4quadrants. This represents 80-90% of sales.-Fairham where cows between 5 and 10 years old are slaughtered toproduce larger patches and strips of 100mm by 45mm.89/12.12/8.2=============32. As a result of the concern voiced of direct inoculation of BSEvia sectioning instruments it was stated that it would be feasible touse new blades with each carcass.COMMENTS ON THE GUIDELINES33. Dr Waine was not convinced of the need for sterile sectioningequipment and separate packaging from the abattoire. He felt thatthis would merely have a cosmetic effect.34. He suggested that the possibility of bovine-human cross-infectionwas very remote.35. He did not believe that it was possible for manufacturers tofollow the guidelines as they stand.PROPOSALS36. Dr Waine felt that the steps taken by the Government had beenrealistic to control the outbreak.REVIEW37. Dr Waine did not believe that any sterilization treatmentproposed would retain the surgical usage of the pericardium.VALVES38. The response has been that this problem is restricted to the U.K.Thier material is obtained from the same Italian source as thepatches. There is no age specification on the cows but the preferenceis for the larger valves which would therefore come from the olderanimals.PORCINE VALVES39. There was a small discussion as to whether these products do fallunder the issued guidelines. The assumption had been made by thecompany that they are not included as pigs are not known to besusceptible to infection by a Scrapie-like agent. This was confirmedby Dr Hoxey.40. The pigs are electrocuted and the heart and pericardium obtainedprior to inspection.41. One abattoire supplies them with most of their porcine requirments.H CampbellPG2CRoom 312 RSQExt. 321212 December 198989/12.12/8.3============TIP740203/3 0241Bovine Spongiform Meeting Held On Friday 26th January 1990Present Dr E Hoxey {chairman)Mr W BurtonDr N RichardsonMrs J DhellMs K TurnerMS H CambellMr N Weatherhead (secretary)copies: Miss Duncan1.ApologiesApologies were received from Miss Duncan2.Minutes of the last meeting.The previous minutes were accepted.3.Matters arising not on the agenda.As agreed at the previous meeting the paper on "Inactivation ofScrapie-like Agents" was sent with a Covering letter drafted byDr Hoxey to all companies that use Bovine or Porcine materiais.4.Report on the STD meeting with ___________________The minutes of the meeting were discussed by the committee it wasnoted that:-a} _____________ now meet DH Guidelines as the devices produced fromthe calf material comply as that they are obtained from animals lessthan 6 months old.The company had written to confirm that they nowsource older animals from overseas.b) _____________ are unable to meet the DH Guidelines.and will not be doing so in the foreseeable future. The panel showedconcern over the stance that BMS are taking. The committee felt that itwas important to arrange a further meeting to inform them that theyare now the only company using UK sourced material. [see minutes of themeeting dated 8/12/89 attached). Dr Hoxey agreed to write separateyto Miss Duncan on this issue.action: Dr Hoxey5. Report on the CSM/MCA BSE working party meeting 10/1/90Mr Burton had produced a note of the above meeting as the minutes hadas yet not been distributed. The committee noted that:-90/01.26/20.1=============TIP740203/3 02421) _______________ has exceeded all expectations tn complyingwith DH Guidelines. They will be sourcing all raw material fromAustralasia from January 1990.2) _______________ are using an international expert _______________to advise them on factory decontamination at the change over of source.3) The use of Dr Taylor and the factory decontamination may qeneratepress interest.4) The offal ban has not yet been expanded to include Scotland.5) The CSM/MCA BSE working group agrees with the approach that STDare taking to Tissue Harvesting and wished to be kept updated.The note of the meeting is attached for reference.6. STD Database updatingMr Burton drafted a minute for signature by Mr Worroll.The object ofthe minute was to enable STD to keep a check on companies that useanimal material in their products.The control manual committee amended the minute and agreed that theaudit report procedure should include (if it does not already) astatement to the effect that the company information section shouldinclude details of raw materials used.The CMC suggested a sentence to the effect "Team leaders visitingBlue Guide companies should additionally take account of Mr Worroll'sminute of Jan 1990." The committee agreed with this sentence and passedit back for inclusion in the Base-line Documents.action N Weatherhead7. Review of the 'Interim Report of the Consultative Committee onResearch into BSE" (Tyrell committee report.)Mrs Dhell presented a summarized Version of the above document to thecommittee. It was noted that only the research studies catorqorisedhigh/medium priority would all somehow receive funding. The committeeexpressed a wish to find out:-1) Areas which have not been prioritised which have relevance toSTDS area of interest.2) Has any party taken up the study "Investigation into the fate ofbovine and ovine tissues and product that could lead to infection byas yet unrecognised routes."90/01.26/20.2==============TIP740203/3 02433. The protocol of work being carried out by the Clinical ResearchLaboratory in Harrow add proposed by the Neuropathogenesis unit inEdinburgh:a) Have they any plans to include pericardium. If not could PD suggestthat they miqht include it.b) What controls are they using.c) Will it be possible to arrange a visit.4) It was suggested that Dr Pickles be contacted as the DHrepresentitive on the Tyrell committee, to enquire if comments onthis document were being sought by the committee, as PD has a numberof points it wishes to raise.8. Incorporation of Guidance into Chemical Methods for the sterilizationof animal tissue Used in medical Devices.The draft paper on methods of validation in chemical sterilization wasshown to the BGRP for comments, these were later received. A copy wasalso forwarded to MCA and despite numerous reminders no reply had asyet been received.The committee recommended that the paper on "Chemical Methods for theSterilization of Animal Tissue Used in Medical Devices" should beamended include Tissue Harvesting. The BGRP will be informed of thisand a copy of tbe document will be presented to the next CMS/MCA BSEworking group which is to be held on 4th July l99O.Mrs Dhell to arrange a meeting to draft this ammendment.Mrs Turneraction:Hr TinklerMrs DhellDr Hoxey9. Possibility of sending STD paper 'Inactivation of Scrapie-likeAgents" to Dr Taylor and Dr Kimberlin for their comments.The committee felt that the paper should be sent to Dr Taylor andDr Klmberlin and that they should be invited to comment. If theysubsequently required payment for this work the committee felt thatthe Department should finance it if necessary.Mrs Dhell will draft a letter to accompany the report for Miss Duncanto sign.action: Mrs Dhell90/01.26/20.3==============TIP740203/3 024410. - presentation on current situationMiss Duncan's report was passed over until the next meeting.1l. Oral discussion on relevant media interest and media reports.The discussion mainly revolved around _____________ and the exposedposition PD would be in if the media became involved. The possiblepress coverage expected in relation to events at ___________ could alsoraise the profile of BSE in "medical" products.Mr Burton to obtain copies of any defensive briefings draftedby MCA in responce to the ______________ situation.N Weatherhead90/01.26/20.4############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############ i recieved the 1947 report of the Louping-ill vaccine incident and posted on www here; Louping-ill vaccine (scrapie transmission by vaccine) THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946 NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND ANNUAL CONGRESS, 1946 snip... The enquiry made the position clear. Scrapie was developing in the sheep vaccinated in 1935 and it was only in a few instances that the owner was associating the occurrence with louping-ill vaccination. The disease was affecting all breeds and it was confined to the animals vaccinated with batch 2. This was clearly demonstrated on a number of farms on which batch 1 had been used to inoculate the hoggs in 1935 and batch 2 to inoculate the ewes. None of the hoggs, which at this time were three- year-old ewes. At this time it was difficult to forecast whether all of the 18,000 sheep which had received batch 2 vaccine would develop scrapie. It was fortunate, however, that the majority of the sheep vaccinated with batch 2 were ewes and therfore all that were four years old and upwards at the time of vaccination had already been disposed of and there only remained the ewes which had been two to three years old at the time of vaccination, consequently no accurate assessment of the incidence of scrapie could be made. On a few farms, however, where vaccination was confined to hoggs, the incidence ranged from 1 percent, to 35 percent, with an average of about 5 percent. Since batch 2 vaccine had been incriminated as a probable source of scrapie infection, an attempt was made to trace the origin of the 112 sheep whose tissues had been included in the vaccine. It was found that they had been supplied by three owners and that all were of the Blackface or Greyface breed with the exception of eight which were Cheviot lambs born in 1935 from ewes which had been in contact with scrapie infection. Some of these contact ewes developed scrapie in 1936-37 and three surviving fellow lambs to the eight included in the batch 2 vaccine of 1935 developed scrapie, one in September, 1936, one in February, 1937, and one in November, 1937. There was, therefore, strong presumptive evidence that the eight Cheviot lambs included in the vaccine althought apparently healthy were, in fact, in the incubative stage of a scrapie infection and that in their tissues there was an infective agent which had contaminated the batch 2 vaccine, rendering it liable to set up scrapie. If that assumption was correct then the evidence indicated that:- (1) the infective agent of scrapie was present in the brain, spinal cord and or spleen of infected sheep: (2) it could withstand a concentration of formalin of 0-35 percent, which inactivated the virus of louping-ill: (3) it could be transmitted by subcutaneous inoculation; (4) it had an incubative period of two years and longer. Two Frenchmen, Cuille & Chelle (1939) as the result of experiments commenced in 1932, reported the successful infection of sheep by inoculation of emulsions of spinal cord or brain material by the intracerebral, epidural, intraocular and subcutaneous routes The incubation period varied according to the route employed, being one year intracerebrally, 15 months intraocularly and 20 months subcutaneously. They failed to infect rabbits but succeeded in infecting goats. Another important part of their work showed that the infective agent could pass throught a chamberland 1.3 filter, thus demonstrating that the infective agent was a filtrable virus. It was a curious coincidence that while they were doing their transmission experiments their work was being confirmed by the unforeseeable infectivity of a formalinized tissue vaccine. As a result of this experience a large-scale transmision experiment involving the ue of 788 sheep was commenced in 1938 on a farm specially taken for the purpose by the Animal Diseases Research Association with funds provided by the Agricultural Research Council. The experiment was designed to determine the nature of the infective agent and the pathogenesis of the disease. It is only possible here to give a summary of the result which showed that (1) saline suspensions of brain and spinal cord tissue of sheep affected with scrapie were infective to normal sheep when inoculatted intracerebrally or subcutaneously; (2) the incubation period after intracerebral inoculation was seven months and upwards and only 60 percent of the inoculated sheep developed scrapie during a period of four and a half years; (3) the incubation period after subcutaneous inoculation was 15 months and upwards and only about 30 percent of the inoculated sheep developed the disease during the four and a half years: (4) the infective agent was of small size and probably a filtrable virus. The prolonged incubative period of the disease and the remarkable resistance of the causal agent to formalin are features of distinct interest. It still remains to determine if a biological test can be devised to detect infected animals so that they can be killed for food before they develop clinical symptoms and to explore the possibilities of producing an immunity to the disease...

8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to contain bovine ingredients). http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf although 176 products do _not_ conform to the CSM/VPC guidelines. http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf

Super-ovulate cattle. (Not to forget about the potential for some BSE cases to come from vaccinations containing pituitary-derived SRMs.)

TWA LITTLE minute

http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf

COMMERCIAL IN CONFIDENCE

http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf

NOT FOR PUBLICATION

http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf

http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf

NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE

snip...

I was quite prepared to believe in unofficial pituitary hormones, also in the 1970's, whether as described by Dr. Little, or in other circumstances, for animal use.

snip...

The fact that there were jars of pituitaries (or extract) around on shelves is attested by the still potent 1943 pituitaries, described in Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the trouble to collect them, they were not lightly thrown out...

When the ban on the importation of embryos and live cattle from North America will be lifted; and [HL3912] What is the scientific evidence for the imposition of a ban on the importation of embryos and live cattle from North America. [HL3913]

Lord Whitty: Her Majesty's Government have not imposed a ban on imports of bovine embryos and live cattle from North America.

The European Parliament and European Council introduced legislation in May last year laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (TSEs). The legislation was introduced in response to the recommendations of the Office International des Epizooties (OIE—the international animal health organisation) and advice from the Commission's scientific comittees. The legislation (and the transitional measures which came into effect in October last year) includes requirement that imports into the EU of bovine embryos and live cattle must be accompanied by certification confirming that the feeding of ruminants with protein derived from mammals has been banned and that the ban has been effectively enforced. Some exporting countries, such as Canada and the USA, are currently unable to meet these new requirements.

Whether the United States contends that under the provisions enforceable by the World Trade Organisation the European Union may not ban the import into Europe from the United States of "specified risk material" (that is, material at possible risk of BSE infection).

Lord Donoughue: Yes. But their position on the Specified Risk Material legislation is based on the assumption that the United States can safely be regarded as a "BSE free" country. Their case for such treatment has not been accepted by the EU Commission's Scientific Veterinary Committee.

Baroness Masham of Ilton: My Lords, as blood products which infected haemophiliacs with HIV came from the USA, is the Minister confident that something else nasty may not come again from imported blood from the USA? Is he aware that there are ways of cleaning blood to make it safer? I know that that is done in Vienna, in Austria. Will the Minister look into that? Following the question asked by the noble Lord, Lord Clement-Jones, about people using their own blood, I am sure that, when this Statement goes out into the wider community, people will want to know that information.

However, the Bio Products Laboratory who produce plasma products did export surplus products, under the Income Generation Regulations for the NHS, and used the income for the benefit of the health service.[21]

43. Do you sell any of it abroad at all? (Mr Gorham) No. The only circumstances in which we would export blood would be if there was an approach to the British Government and the British Government felt that it was appropriate to support an international emergency or something like that. We do supply the British Forces. We occasionally help out our colleagues in Wales and Scotland and they would reciprocate with us if that was appropriate. At the moment it is more or less totally contained within the United Kingdom.

Mr. Hinchliffe: To ask the Secretary of State for Health what estimate he has made of the number of persons who have been inoculated with blood or blood products over the past three years in the United Kingdom. [61681]

Ms Jowell [holding answer 2 December 1998]: It is estimated that about one million people in the United Kingdom receive blood and blood products every year.